Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
Lead quality assurance activities, ensuring high standards are maintained across clinical projects.
Guide teams in compliance with industry regulations and best practices while fostering a culture of continuous improvement.
Mentor QA staff and drive the quality objectives within a dynamic and growing organization.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. The system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Ensure adherence to regulations and contractual obligations.
Develop and update compliance policies and SOPs.
Conduct internal compliance audits and report findings.
Equip is a virtual, evidence-based eating disorder treatment program. They aim to ensure that everyone with an eating disorder can access effective treatment, operating in all 50 states and partnered with most major health insurance plans. Since its founding in 2019, Equip has maintained a fully virtual environment.
Lead and oversee end-to-end clinical trial operations from study start-up through close-out.
Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.
Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single-asset companies to improve productivity.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.